Adult | Age
Item
adult subjects 18-65 years of old, inclusive
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis C Duration | Plasma Hepatitis C virus RNA assay
Item
documented chronic hcv infection to be of at least 6 months duration and plasma hcv rna ≥ 5 log10 iu/ml at screening.
boolean
C0524910 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0032105 (UMLS CUI [2,1])
C1272251 (UMLS CUI [2,2])
Hepatitis C virus Therapy naive | PEGINTERFERON | Interferon | Ribavirin | Therapeutic procedure To be stopped
Item
hcv treatment naïve or peg-ifn, ifn, and/or rbv experienced (treatment must have ceased at least 3 months prior to screening). treatment experienced subjects should not exceed 40% of the subjects enrolled in each cohort
boolean
C0220847 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0982327 (UMLS CUI [2])
C3652465 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Hepatitis C Genotype | Cohort Number
Item
mono-infection with hcv genotype 1a for cohorts 1, 2, 3, 4, and 5 and mono-infection with hcv genotype 1b for cohort 6 and 7.
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0599755 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Creatinine clearance measurement Estimated
Item
estimated creatinine clearance ≥ 70 ml/min,
boolean
C0373595 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
QTC interval QTcF - Fridericia's Correction Formula | Gender | QRS duration | PR interval duration
Item
qtcf interval ≤ 450 msec for males and ≤ 470 msec for females, qrs duration < 120 msec, pr interval < 220 msec,
boolean
C0489625 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0429025 (UMLS CUI [3])
C0429024 (UMLS CUI [4])
Body mass index
Item
body mass index (bmi) of 19.0 to 34.0 kg/m^2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Urine drug screen positive Illicit Drugs
Item
urine drug screen positive for illicit/illegal drugs
boolean
C0743300 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt and ast levels > 5 times the upper limit of the normal range (uln)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Direct bilirubin increased | Hepatic decompensation | Platelet Count measurement | Prothrombin time increased | Albumin measurement
Item
direct bilirubin > uln, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets < 90,000/mm^3, prothrombin time ≥ 1.5 × uln and albumin < 3.5 g/dl) are not eligible for study participation.
boolean
C0740434 (UMLS CUI [1])
C1394798 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0151872 (UMLS CUI [4])
C0201838 (UMLS CUI [5])
Absolute neutrophil count | African American | Hemoglobin measurement
Item
subjects with an absolute neutrophil count (anc) < 1,000 cells/mm^3 (< 750 cells/mm^3 for black or african-american subjects), hemoglobin (hb) < 11 g/dl,
boolean
C0948762 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
HBV coinfection | Human immunodeficiency virus (HIV) coinfection | HCV coinfection Genotype
Item
coinfected with hepatitis b virus (hbv), human immunodeficiency virus (hiv), or another hcv genotype other than genotype 1a/b are not eligible for study participation.
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
C1698259 (UMLS CUI [3,1])
C1533728 (UMLS CUI [3,2])
Liver carcinoma | Alpha one fetoprotein measurement | Ultrasonography | Standard of Care
Item
evidence of hepatocellular carcinoma (e.g., a-fetoprotein > 50 ng/ml or as indicated by recent ultrasound or other standard of care measure)
boolean
C2239176 (UMLS CUI [1])
C0201539 (UMLS CUI [2])
C0041618 (UMLS CUI [3])
C2936643 (UMLS CUI [4])
Heart Disease | Electrocardiogram abnormal | Prolonged QTc interval QTcF - Fridericia's Correction Formula | Gender | QRS duration | PR interval duration | Bradycardia beats per minute | Second degree atrioventricular block | Complete atrioventricular block
Item
history of significant cardiac disease. the following ecg abnormalities at screening are exclusionary: qtcf (qt corrected using fridericia's formula=qt/rr^0.333) > 450 msec for males and > 470 for females; qrs > 120 msec (left or right hemiblock is not exclusionary); pr interval > 220 msec; bradycardia (< 45 beats per minute); second or third degree heart block.
boolean
C0018799 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C1560305 (UMLS CUI [3,1])
C1882513 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4])
C0429025 (UMLS CUI [5])
C0429024 (UMLS CUI [6])
C0428977 (UMLS CUI [7,1])
C0439385 (UMLS CUI [7,2])
C0264906 (UMLS CUI [8])
C0151517 (UMLS CUI [9])
Illness Clinical Significance Interferes with Therapeutic procedure | Illness Clinical Significance Interferes with Assessment | Illness Clinical Significance Interferes with Protocol Compliance
Item
history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])
C0221423 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
Gastrointestinal Disease Interferes with Absorption Investigational New Drug | Gastrointestinal Disease Interferes with Anatomy gastrointestinal | Gastrointestinal Disease Interferes with Gastrointestinal Motility
Item
history of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0700276 (UMLS CUI [2,3])
C0521362 (UMLS CUI [2,4])
C0017178 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0017184 (UMLS CUI [3,3])